1. Field Of The Invention
The present invention relates to magnetic devices for therapeutic application to the human body, and more particularly to an electromagnetic quadripolar treatment device with a focusing means to increase the intensity, focus and gradient of the field for placement against or in proximity to the human body. The present invention further relates to methods of use of such magnetic treatment devices for the treatment of various animal diseases, complications and disorders such as such as, but not limited to, a) pain and swelling, b) cardiac dysfunction, c) drug resistant seizures and cerebral edema, d) pain and edema sustained in severe bums, e) potentiation of pharmaceutical agents, f) treatment of strokes and protection from cell death following hypoxic injury, g) control of edema and pain and speeding healing following surgical procedures and speeding healing rates of chronic non-healing wounds, and h) control of pain and sludging of sickled cells in sickle cell disease.
2. General Background
Magnetic fields have been applied to the human body for various therapeutic purposes for many centuries. For example, magnetic medical treatment devices for application against selected portions of the human body are disclosed in U.S. Pat. No. 3,921,620; method and apparatus for suppressing neuron action potential firings U.S. Pat. No. 5,312,321; magnetic plasters for improving circulation are disclosed in U.S. Pat. No. 4,489,711; magnetic fields for stimulation of bone growth are disclosed in U.S. Pat. No. 4,105,017; and magnetic stimulation of nerve cells has been accomplished with devices such as the Cadwell Magneto-Electric Stimulator (MES-10) manufactured by Cadwell Laboratories, Inc. of Kennewick, Wash.
Various disease states, tissue and organ malfunction may be the result of loss of membrane stability and normal permeability. These membranes may be cellular or intracellular, but in any case represent malfunction of excitable tissue. This malfunction of excitable tissue may be due to alteration of ion channel function. These various disease and states of malfunction may also be related to alteration of receptor sites or agonist sites of enzymes and/or other such dynamic systems within living organisms and more particularly the human animal. A great variety of symptoms and malfunctions may occur, such as, but not limited to, the above listed disease and/or disorder states.
Unfortunately, many types of ailments, including chronic pain, poor localized blood flow, cerebral edema and certain seizures and injuries cannot be successfully treated with conventional drug, physical therapy or surgical therapies. Because such ailments are often untreatable with conventional therapies, there is a need for alternative therapies that relieve these previously untreatable or poorly treatable conditions.
Accordingly, it is an object of this invention to provide a device that alters the stability of excitable membranes and other charged structures and systems in order to treat aliments of animals.
Another object of the invention is to provide an electromagnetic device for production of an electromagnetic field for treatment of such disorders, such a devise being electromagnetically powered, and having, inter alia, an alternating polarity, quadripolar array which generates a 3 dimensional, steep field gradient.
It is a further object of this invention to provide a device which contains a flux return ring on the back surface away from the body surface which is designed to return the magnetic flux thereby increasing the strength and gradient without altering the center charge and symmetry of the 3 dimensional steep gradient field.
Another object of the invention is to provide a flux focusing ring surrounding the DC electromagnetic coils on the outer perimeter stationed midway between the top and bottom of the flux core of the pole. Attachment means is provided to hold the focusing ring to the outer perimeter of the coils.
It is a further object of the invention to provide an electromagnetic pole of like polarity on the outer surface of each of the 4 poles of the invention such that the top of the core is oriented to the geometric side of the pole such that the axis of the two magnets form a 90.degree. angle. The focusing magnet comprises an iron pole, an iron housing and a copper wire coil.
It is a further object of the invention to control each focusing magnet by a separate rheostat such that the focusing ring containing magnets can focus and balance the symmetry of the therapeutic field.
Additional object of the current invention is to present an array of embodiments for a variety of therapeutic purposes.
A further object of this invention is to reveal a method of design and manufacture of an iron core which will produce a center charging homogenous, static magnetic flux and decreased heat production from EMF induced adherent heat producing currents (referred to as Eddy Currents in AC EMF circuits). In AC circuits, "Eddy" currents are currents due to induced EMF and account for some of the losses in electrical equipment. If we consider a solid iron rotor of a generator or motor, the solid iron rotor cuts magnetic lines of force as it rotates the same as the wire coil of the rotor. The coil has an EMF induced in it in the direction as dictated by "Fleming's Rule" as the "left-hand rule." The iron core also has an EMF induced in it in the same direction as the coil. This iron core is a low resistance circuit and the current does no work, but merely heats the iron core. The current flow in the core generates a secondary magnetic flux which is of higher frequency than the 60 cycle current and is more aberrant due to the variable resistance of the non-homogenous iron. The higher frequency magnetic flux is erratic due to the reverberating nature of the "Eddy" Currents in the iron core. The resistance of any given position of the conductor in ohms divided into the electromotive force in volts is equal to the current flow in amperes. In the non-homogenous core with lack of continuity of the base-metal crystal structure. The heating effect of the current is proportional to the square of the current. These currents are commonly called "Eddy" currents, but are also known as Foucault currents.
The dominant thinking today suggests that such negative currents do not exist in DC electromagnetic circuits. In the current invention similar currents are a factor which must be dealt with in the design. The predecessor device of the current invention consists of a magnetic flux generator and a D/C static drive power source. The magnetic flux generator comprises a plurality of electromagnetic bodies having at least four magnetic poles substantially in a single plane, the magnetic poles being oriented to define the four vertices of a quadrilateral shape. The four magnetic poles comprise two positive and two negative poles, the two positive poles defining opposite diagonal vertices and the two negative poles defining opposite diagonal vertices of the quadrilateral shape. Each of the magnetic poles are magnetically attracted to the two oppositely charged poles and magnetically repelled by the like charged poles. Each of the electromagnetic poles include a conducting wire wound around a cast iron core. The wire may be comprised of any conducting material (copper or aluminum). The core and winding are supported by a cast iron housing. The poles are electrically wired in parallel and are charged by a DC power source. The cast iron housings and cores being porous, non-homogenous cast iron has varying resistivity and is the victim of mutual induction in adjoining coils. The induced current follows Flemming's rule. The induced current flows in opposite directions in the adjoining coils. In this system, the current flow in adjoining poles is in the opposite direction, therefore the induced current augments the current in adjoining poles and decrease the current in diagonally opposing poles. This lack of homogeneity in the iron conductor with fluxing resistivity (as a current flow pathway heats, the current flow finds a path of less resistance, the former path then tends to cool because of decreased current flow-the summation effect is seen as reverberation of resistance and therefore current flow [amps=Resistance in volts/ohms]) and unbalanced induction causes reverberation in the DC flux fields which moves lines of flux across the poles. This brings about an erratic EMF in the core and cast iron housing. We will call these higher frequency erratic currents "Holcomb's Currents." Work in human and animal models reveal that these currents cause heat generation in the poles and reduce or cancel beneficial therapeutic effects of the steep gradient three dimensional magnetic flux fields. These high frequency erratic currents can be minimized by a process of lamination. The lamination reduces magnetic hysteresis and erratic currents. Lamination can't be used, however, in this invention because it distorts the symmetry of the field.
Another object of the invention is to reveal a new process for the production of magnetically soft materials in which the continuity of the base-metal crystal structure is undisturbed and homogenous. A method of producing a course grain homogenous core is revealed. Suitable grain size is attained by grinding silicon electrical steel or Permalloy (a high nickel iron alloy) to a powder of suitable grain size, treated with a powerful, silica colloid polymer, placed into molds and annealed under high pressure. The resulting core is homogenous with uniform orientation of the base-metal crystal structure which provides crystal structure continuity, uniformity, low aberrant current formation and low hysteresis as well as high saturation of magnetic induction.
Various embodiments of the use of the electromagnetic field produced in the instant invention include the following, but are not limited to the following.
A. Pain and Swelling (SMS-P)
1. Acute Pain and Edema
It is a further object of the invention to provide a device that alters nerve cell behavior in a manner that reduces painful sensations.
Another object of the invention is to provide an apparatus for applying a variable symmetric quadripolar, three dimensional magnetic flux which is focused and balanced to the human body to stabilize excitable membranes and thereby reduce pain and edema associated with acute injury, inflammation or surgical procedure.
Another object of the invention is to provide a specialized magnetic flux field to control and reverse the swelling associated with acute injury, inflammation and surgery.
A further object of the invention is to provide a method for applying a therapeutic electromagnetic device to the human body to relieve pain, improve blood flow and reduce swelling associated with injury, surgery or acute inflammation.
2. Chronic Pain
It is a further object of the invention to provide a device that alters nerve cell behavior in cases of chronic pain to block the spontaneous pacemaker firing of the chronically malfunctioning pain fiber (mostly A.delta. and C-fibers).
B. Magnetic Treatment Device for Cardiac Dysfunction Static Magnetic Stabilizer--(SMS-C)
This application of the present invention relates to magnetic devices for therapeutic application to the human body, and more particularly to an electromagnetic quadripolar treatment device for placement in an intensive care unit bed for the treatment and control of cardiac arrhythmia, improvement of cardiac blood flow and to control chest pain by applying the electromagnetic quadripolar flux generator either over or underneath the chest of a patient with acute myocardial infarction and/or arrhythmia. The three dimensional flux field gradient when applied to the area of the heart controls arrhythmia, improves blood flow, controls angina and protects ischemic myocardial muscle from cell death.
Myocardial infarction with secondary fibrillation and/or heart failure accounts for the leading cause of death in the United States. Myocardial infarction occurs secondary to occlusion of arterial blood supply to a portion of the myocardium. This occlusion can occur either secondary to blockage by atherosclerotic plaques and/or arterial spasm. This event results in chest pain, potential dysarrhythmia, potential fibrillation, and potential heart failure secondary to decrease in inotropic contraction of the myocardium. Each of these events are treated by drug intervention with varying success. In the event that the myocardium fibrillates, this constitutes a medical emergency of the greatest magnitude. The heart must be immediately defibrillated. The current therapy is to place a DC capacitor driven high voltage discharge across the myocardium by applying two paddles to the chest wall and discharging a surge of high intensity DC current. This surge of high voltage DC current will depolarize the myocardium and allow the fastest pacemaker tissue within the heart to assume pacemaker function i.e. the atrial pacemaker. In most instances the myocardium is so irritable and prone to recurrent spontaneous fibrillation that drugs such as I.V. xylocaine must be given to stabilize the electrically irritable myocardium. These drugs are mostly sodium channel blockers and as such they decrease the inotropic and chronotropic contraction of the myocardium. If inadvertent overdosage occurs, the pumping action of the heart may be decreased to below a critical level. Drugs such as epinephrine may need to be used to maintain blood pressure and increase the inotropic and chronotropic contraction of the heart, as well as to increase blood vessel tone. Revival of a patient who fibrillates as a consequence of a myocardial infarction requires rapid manipulation of D/C defibrillation and careful drug manipulation.
The current acute therapy for myocardial infarction and its frequent complications has many side effects. DC defibrillation of the heart causes myocardial damage with each exposure to the D/C discharge. Therefore with each needed defibrillation the chances of recovery progressively decrease. Use of xylocaine to stabilize the myocardium is accompanied by decrease in contraction of the myocardium and decrease in vascular tone. The subsequent use of epinephrine may induce fibrillation and increase the after load on the heart enough to cause congestive heart failure. This condition is clearly a life threatening disorder frequently resulting in death or permanent disability. Because this ailment is often poorly responsive to conventional therapy, there is a need for alternative therapy that will defibrillate the myocardium without cellular damage, stabilize the myocardium without decreasing the desired function, dilate the arteries of the heart for better blood flow, control myocardial pain and prevent cell death.
Accordingly, it is an object of this invention to provide a device that alters myocardial behavior in a manner which stops fibrillation, stabilizes the electrical activity, dilates myocardial arteries and controls chest pain which is secondary to ischemia. It is a further object of this invention to limit the extension of the infarction and to limit cell death which is secondary to ischemia.
Another object of the invention is to provide a magnetic device that alters myocardial behavior in a manner which controls myocardial ischemia, fibrillation, chest pain and extension of the infarction.
Another object of the invention is to provide a magnetic device that alters myocardial behavior by altering sodium and calcium channel functions such that the quadripolar, alternating polarity and the subsequent field gradient blocks varying degrees of sodium and calcium channel function. The degree of blockage is related to the gradient and strength of the field. The gradient and the field strength may be manipulated by this technology.
It is a further object of the invention to provide an apparatus for applying a variable magnetic flux to the human body in the area of the heart.
It is a further object of the invention to provide an apparatus for applying an instantaneous high intensity magnetic flux designed to defibrillate the myocardium of a human.
C. Magnetic Treatment Device for the Control of Drug Resistant Seizures and Cerebral Edema--Static Magnetic Stabilizer (SMS-E)
This application of the present invention relates to magnetic devices for therapeutic application to the human body, and more particularly to an electromagnetic dual quadripolar treatment device for placement on either side of the human head for control of seizure discharges and cerebral edema.
Seizure activity in the brain is a rather common occurrence. Clinical seizures result from uncontrolled firing of brain neurons. This uncontrolled spontaneous discharge may have projections to many parts of the brain, causing a variety of clinical presentations. These seizures are controlled in many patients by anticonvulsant drugs which work through the alteration of ion channels. The drugs increase the seizure threshold by stabilizing neuron cell wall permeability to ion flux. Many of these seizures are not well controlled by medication nor any other available modalities. A significant number of these seizures are resistant of all modalities of treatment. These patients present to the hospital in a state of continuous uncontrolled seizure activity. This condition is referred to as Status Epilepticus, which is a medical emergency requiring prompt attention. Patients in Status Epilepticus, if not controlled quickly, develop brain hypoxia and resultant hypoxic ischemic encephalopathy. This is a life threatening disorder, frequently resulting in severe brain damage or death. Because this ailment is often untreatable (drug resistant Status Epilepticus) by conventional drugs, there is a need for alternative therapies that stabilize the abnormal irritable neuron cell wall electrophysiology.
Accordingly, it is an object of the invention to provide a device that alters brain neuronal behavior in a manner which stops the abnormal electrical discharge of the neurons, therefore stopping the seizures.
Another object of the invention is to provide a magnetic device that alters brain neuronal behavior in a manner which stops and controls drug resistant seizures.
Another object of the invention is to provide a method for applying a "dual head" therapeutic electromagnetic device to the human head to relieve seizures.
It is a further object of the invention to provide an apparatus with two magnetic flux head generators made with opposite poles facing, having 4 poles per head and alternating polarity such that the field gradient will be enhanced and the total energy applied to the brain will be increased over that which may be delivered by a single head on the device.
D. Magnetic Treatment Device for Control of Pain and Edema Sustained in Severe Burns--Static Magnetic Stabilizer for Burns (SMS-B)
The present invention relates to magnetic devices for therapeutic application to the human body, and more particularly to an electromagnetic multiple quadripolar treatment device for placement on the human body for control of pain and edema sustained in sever burns.
Severe burns of the human body constitute a medical emergency. Shock secondary to pain is a problem of major magnitude. Shock from hypovolemia is very difficult to control. The burned skin, especially 2nd and 3rd degree burns, leak fluid, electrolytes and protein. These severe consequences of a severe burn are related to stimulation of pain fibers and loss of cell integrity. Current therapy consists of narcotic analgesics, replacement of water, electrolytes and protein, as well as body temperature regulation. These are supportive measures. There is a need for adjunctive therapies that control pain, repair membrane integrity, control edema and stimulate healing.
Accordingly, it is an object of the invention to provide a device that alters pain fiber firing, repairs membrane integrity, controls edema in the area of the burn and promotes healing.
Another object of the invention is to provide a magnetic device that alters the permeability of burn damaged cells such that they are less permeable to water, ions and protein.
Another object of the invention is to provide a method of applying a therapeutic electromagnetic device to the human body after a serious burn injury.
It is a further object of the invention to provide an apparatus with three movable magnetic flux head generators (with flux and power focusing means, to control the gradient and the power) made with the ability to rotate on each side of the burn bed up to 30.degree. to 45.degree. above the surface of the bed which contains a burn patient.
An additional object of the invention is to provide an apparatus with four magnetic flux head generators mounted on a rotating bar, having four poles per head and alternating polarity such that the field gradient will be enhanced and the total energy applied to the burned body will be increased in relationship to the degree of burn.
E. Magnetic Treatment Device for Potentiation of Pharmaceutical Agents (SMS-D)
The present invention relates to magnetic devices for therapeutic application to the human body, and more particularly to an electromagnetic quadripolar treatment device for placement on the human body for control of various disease processes through its interaction with drugs and drug receptors.
Pharmacological agents are used extensively in our society for a variety of diseases, injuries and infectious states. All drugs exert multiple effects on the living organism. The dominant and desired effect is referred to as the therapeutic effect, and the less dominant and undesirable effects are referred to as side effects. All drugs have side effects, many of which are dangerous and/or lethal. Drug effects are mediated by receptor interaction with a receptor agonist. This is an intermediate step in all drug effects.
Accordingly, it is an object of the invention to provide a device that alters receptor configuration and/or drug receptor interaction. The effects may be agonist or antagonist effects. That is, the interaction may potentiate or inhibit drug effects and/or side effects.
An additional object of the invention is to provide a magnetic flux device comprised of an apparatus with four focused magnetic head generators mounted on a flux return ring. These are then surrounded by a flux return focusing ring with a focusing head at a 90.degree. angle to each pole. This device may be focused to any portion of the body, such as the head, in order to bring about potentiation of therapeutic effects of certain drugs.
It is a further object of the invention to present data which demonstrates the potentiation of phenytoin on the control of drug resistant seizures, the potentiation of lidocaine on inhibition of C-fiber firing and the blockage of activation of calcium channels in C-fibers by capsaicin.
F. Magnetic Treatment Device for Treatment of Strokes-For Protection from Cell Death Following Hypoxic Injury (SMS-S)
This application of the present invention relates to magnetic devices for therapeutic application to the human body, and more particularly to an electromagnetic dual quadripolar treatment device for placement on either side of the human head for the application of a quadrilateral, steep, three dimensional magnetic flux field gradient.
Cerebral ischemia can be either focal or global, implying hypoperfusion of the entire brain. Ischemia is secondary to reduction of cerebral blood flow either locally or globally. Histologically selective neuronal necrosis may occur even after brief periods of global ischemia, and after focal ischemia there may be regions of pan necrosis in the territory of the affected artery. Progressing stroke is an observed deterioration after the initial insult that can occur for 48 to 96 hours. This phenomenon is likely related to a combination of evolving thrombosis and progressive cell death. Cell death occurs secondary to hypoxia, spillage of excitatory neurotransmitters, and spillage of calcium secondary to dying cells in the region.
It is the purpose of this invention to present data on mice which demonstrates protection from cell death in animals who have demonstrable ischemia secondary to prolonged status epilepticus. Data will also be presented which demonstrates protection from brain cell death following direct injection of toxic amino acids into the lateral ventricles.
A further purpose of this invention are planned clinical trials for protection from cell death and the reduction of edema in intracranial hemorrhage, strokes and spinal cord injuries.
G. Magnetic Treatment Device of this Invention for Control of Edema and Pain as well as to Speed Healing Rates Following Surgical Procedures. Speed Healing Rates of Chronic Non-healing Wounds (SMS-O)
Following surgical procedures, pain, edema, hyperalgesia, healing rate and scar formation are for the large part not treatable except with time and the natural healing process. Non-healing or slowly healing wounds are treated in a variety of ways including hyperbaric oxygen. Non-healing of wounds is mostly due to poor circulation.
Accordingly, it is an object of this invention to provide a device that produces a three dimensional, magnetic, steep gradient, flux field generator for the purpose of therapeutic application to the human body in the area of a post surgical wound or a chronic non-healing wound. The purpose is to control pain, edema, hyperalgesia, speed healing rates, decrease scar formation and speed the healing of chronic wounds by increasing blood flow to the wound.
H. Magnetic Treatment Device of this Invention for the Control of Pain and Sludging of Sickled Cells in Sickle Cell Disease
Sickle cell anemia is due to an abnormal amino acid sequence in the beta globin chain of adult type (A) hemoglobin. The sickling process is often initiated by low oxygen tension and low PH. The sickled cells obstruct small vessels, and infarcts are frequent. Infarction accounts for the abdominal pain, bone pain, and gradual decrease in the size of the spleen. Current treatment is instituted primarily for the crisis. There is no known effective method for reducing the rate of chronic hemolysis or preventing crisis. The current treatment of choice is red cell transfusion. Other measures are good hydration, oxygen, analgesics and in some cases corticosteroids. A number of antisickling drugs are under evaluation, but none look very promising.
Accordingly, it is another object of this invention to reveal a method of using the variable, quadripolar, three dimensional field gradient of the invention to control the sickling of the blood cells, control pain and sludging associated with sickle cell crisis, and the prophylactic use of the invention in the prevention of sickle cell crisis.
The above-described embodiments are merely provided as illustrative examples of the instant invention and are not intended to limit the scope or spirit of the instant invention.